MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-04-30

Brief Summary

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The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with standard percutaneous transluminal angioplasty (PTA).

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Detailed Description

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Conditions

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Femoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion Popliteal Artery Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MDT-2113 Drug-Eluting Balloon

Paclitaxel drug-eluting angioplasty balloon

Group Type EXPERIMENTAL

MDT-2113 Drug-Eluting Balloon

Intervention Type DEVICE

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Standard angioplasty balloon

Standard PTA balloon without Paclitaxel drug-elution

Group Type ACTIVE_COMPARATOR

Standard angioplasty balloon

Intervention Type DEVICE

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Interventions

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MDT-2113 Drug-Eluting Balloon

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Intervention Type DEVICE

Standard angioplasty balloon

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: ≥ 20 years and ≤ 85 years
* Documented ischemia with Rutherford classification 2, 3, or 4
* Able to walk without assistive devices
* Target lesion is in the SFA and/or PPA above the knee
* Target lesion consists of a single de novo or non-stented restenotic lesion (or tandem lesions) or is a combination lesion that meets the following criteria:

1. ≥ 70% and \< 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm
2. 100% occluded with total lesion length ≤100 mm
3. Combination lesions must have total lesion length ≥40 mm and ≤200 mm with an occluded segment that is ≤ 100 mm in length (by visual estimates)
* Reference vessel diameter ≥ 4 mm and ≤7 mm (by visual estimate)
* Angiographic evidence of adequate distal run-off through the foot

Exclusion Criteria

* Stroke or STEMI within the 3 months prior to enrollment
* Either local or systemic thrombolytic therapy within the 48 hours prior to the index procedure
* Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT)
* Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies or to paclitaxel, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure
* Chronic renal insufficiency
* Subject is enrolled in another investigational device, drug, or biologic study
* Any major surgical procedure or intervention performed within the 30-day period prior to or post index procedure
* Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure
* Failure to successfully cross the target lesion
* Angiographic evidence of severe calcification
* Target lesion known in advance of enrollment to require treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, cutting balloons, scoring balloons; use of embolic protection devices is also prohibited

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No